Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

FDA 40

FDA FDA Approval Regulations Production 40

Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. The Coke Ovens: Pushing, Quenching, and Battery Stacks NESHAP, subpart CCCCC, was promulgated pursuant to section 112(d) of the CAA on April 14, 2003.

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

Production 52

Production International Trials Government 52

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. The Complaint nowhere alleges that either the persons allegedly targeted or the persons purportedly targeting their “wild conspiracy theories” have any connection to Texas, which leaves us wondering how the Texas Deceptive Trade Practices Act (“DTPA”) could possibly apply. See Henry Schein, Inc. Stromboe , 102 S.W.3d

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59